Clinical Pharmacologist (7143)

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Our client is headquartered in Switzerland – a biotech-hub of Europe – is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking for a Clinical Pharmacologist for a initial 24 months contract based in

Basel area.

The Clinical Pharmacologist contributes to the design, conduct, analysis, interpretation, and reporting of clinical pharmacology trials across drug development.

The role provides scientific and medical input to trial teams, supports protocol and trial document development, and contributes to regulatory and cross-functional activities.

The position also supports PK/PD data interpretation, trial planning, and communication of trial results.

Work is performed in close collaboration with internal stakeholders and under appropriate line management supervision where applicable.

Main responsibilities

• Individual
• Develop the ability to work independently and flexibly under supervision and provide deliverables in good quality and in a timely manner
• Ability to pro-actively gather relevant clinical pharmacology knowledge related to assigned compounds and willingness to undertake relevant internal/external training courses
• Compliance with internal working practices/SOPs, quality control procedures, and regulatory guidelines
• Leadership of phase I/IIa studies including writing and/or review of clinical trial protocols and other trial-related documents to deliver on time, on budget, and with the appropriate quality
• Contribution to the writing of the clinical sections of regulatory or safety-related documents (e. g., Investigator's Brochure, IMPD, briefing books, DSUR, CP sections of NDA)
• Comprehensive understanding of the science related to a trial and/or project
• Response to scientific/medical inquiries from IEC/IRB and/or Health Authorities
• Responsibility for data review prior to database lock
• Responsible for all aspects of trial protocols, reports, statistical analysis plans, project summaries, and development plans
• Preparation of or contribution to scientific publications and position papers, including supportive literature reviews
• Provision of input/expertise to the PK/PD section of protocols for phase IIb-IV studies
• Comprehensive understanding of science/medicine related to a project together with a broad, innovative, science-based, and forward-looking strategy
• Elaboration of the Clinical Development Plan for the assigned compound when in early-stage development (i. e., phase I and II) and/or contribution to it when in later stages of development.
• Elaboration of CP trial plans for assigned projects
• Development and maintenance of contacts with key opinion leaders and investigators
• Development of line management experience (with support from the line manager as necessary)
• Shared
• Attendance of CP group and other educational meetings with active contribution (e. g., presentations when requested)
• Contribution to the selection and supervision of negotiations with CROs (e. g., clinical, data management, biostatistics, and bioanalytical CROs) and management of monitoring aspects
• Primary liaison person in the CP trial team by providing appropriate input to the trial team regarding medical/scientific aspects related to a trial and/or project
• Contribution to the preparation of submission documents to Independent Ethics Committee/ Institutional Review Board (IEC/ IRB) and Health Authorities
• Interpretation and presentation of trial results to Life Cycle Team, Development Team, and externally when appropriate (e. g., scientific advisory board, investigator meeting, congress, health authorities, etc.)
• Close collaboration with the Modeling and Simulation group within CP
• Attendance to scientific meetings and review of literature to remain aware of the latest clinical and scientific developments related to a project
• Representation of CP in context of due diligences
• CP representative within the project team for one or several projects including provision of clinical pharmacology expertise at trial/project team and other relevant meetings
• Promotion of communication and alignment across line functions in the project team
• Participation in Health Authority meetings as CP representative and contribution to regulatory documents (e. g., briefing book)

Qualifications and Experience

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• Strong academic background, i. e., MSc (or equivalent), preferably a Ph D, Pharm D, and/or MD.
• 2-4 years of hands-on

Clinical research experience in academic or industry environment but preferably with drug development experience in a Pharmaceutical/Biotechnology company, mainly in phase 1.

• Experience in designing, conducting, and analysing CP studies and ability to elaborate good-quality CP trial protocols.

PK/PD evaluation techniques and knowledge about associated regulatory guidelines.

Ability to carry out PK, PD, and PK/PD analysis using Win Nonlin or similar software, graphical presentations, interpret and summarize resulting data.

• Understanding of the roles and responsibilities of relevant functions involved in a clinical trial
• ICH-GCP and other relevant guidance documents/regulations for clinical trial authorization
• Knowledge of and experience in interacting with other departments involved in drug development
• Scientific/pragmatic approach to data analysis and interpretation with necessary attention to details
• Highly self-motivated, proactive working attitude
• Well-developed interpersonal skills including ability to act as a team player
• Clear communication style (verbal and written)
• Adequate general IT skills (e. g., MS office) and Ability to keep data, related documentation, and files in a well-organized manner
• Willingness and ability to travel as required.
• Ability to work in a matrix environment and adequately manage the interaction with multiple stakeholders by providing timely, good-quality feedback and input.
• Ability to simultaneously handle and oversee multiple tasks, to adapt to changing project needs and to prioritize in a high-pace environment.
• Fluency in English is mandatory.
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